August 12, 2014

Sanofi on Tuesday announced that it has launched an authorized generic version of Eloxatin (oxaliplatin injection) through Winthrop U.S., the company’s generics division. 

August 11, 2014

The Food and Drug Administration last week released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act, Bloomberg BNA reported.

August 11, 2014

Fred's Super Dollar and Cardinal Health on Monday announced a multi-year agreement for Cardinal Health to be the new primary supplier of branded and generic pharmaceutical products.

August 11, 2014

Mylan announced the launch of capecitabine tablets USP in 150-mg and 500-mg dosage strengths, a generic version of Xeloda tablets from Genentech.

August 8, 2014

The BBC on Tuesday reported that a team has developed an app and small lens add-on that allows blood-cell analysis via a smartphone.

August 6, 2014

BD Medical, a segment of BD, on Wednesday announced the retail pharmacy launch of BD AutoShield Duo, the only pen needle with patented dual front- and back-end shields that provides greater convenience and safety before and after injecting. 

August 5, 2014

Lannett Co. on Monday announced that its abbreviated new drug application for oxycodone hydrochloride capsules, 5 mg, has been approved by the Food and Drug Administration.

August 5, 2014

One-in-four Americans admits that they have misused prescription drugs, according to a new national survey by FindLaw.com.

 

August 4, 2014

Cardinal Health on Monday reported fourth-quarter fiscal 2014 revenue of $23 billion, down 9.8%.

 

August 4, 2014

The Pennsylvania House of Representatives unanimously adopted House Resolution 938, which designates August as National Immunization Awareness Month, the legislature announced Monday.

July 31, 2014

Dr. Reddy's Labs announced financial results for the quarter ended June 30, which includes consolidated revenues of Rs.35.2 billion, representing year-on-year growth of 24%.

July 31, 2014

The Food and Drug Administration on Friday will publish the fiscal year 2015 generic drug user fee rates as required under the Food Drug and Cosmetic Act as amended by the Generic Drug User Fee Amendments of 2012.

July 31, 2014

Teva Pharmaceuticals on Thursday announced results for second-quarter 2014, which included revenues of $5 billion, an increase of 2% compared with the same period last year.

July 31, 2014

McKesson on Thursday reported revenues of $44.1 billion for the first quarter ended June 30, up 37%. 

July 30, 2014

Perrigo on Wednesday announced that it has filed an abbreviated new drug application with the Food and Drug Administration for desoximetasone topical spray 0.25%. The company also has notified Taro Pharmaceuticals U.S.A., the owner of the reference listed drug, of the filing.

July 29, 2014

The use of FDA drug safety programs to prevent generic competition is costing the American health care system and patients $5.4 billion in annual pharmaceutical spending.

July 29, 2014

The Food and Drug Administration may have more generic drug applications than it does personnel to process them, according to a Wall Street Journal report published Tuesday.

July 28, 2014

The Food and Drug Administration has accepted a license application by Sandoz, Novartis' generics company, for a potential generic biologic drug, the company announced Monday.

July 23, 2014

Generics supplier Camber Pharmaceuticals added two new executives to its team this week, bringing on Kirk Hessels as marketing director and Amanda Rebnicky as its sales operations director.

July 23, 2014

Mylan on Wednesday announced that U.S. District Court for the district of New Jersey granted a temporary restraining order against Apotex Inc. and Apotex Corp. relating to Paroxetine CR.

July 22, 2014

The Food and Drug Administration has granted tentative approval to Teva Pharmaceutical for abacavir sulfate and lamivudine tablets, according to agency records.

July 22, 2014

Lupin, along with certain U.S. drugmakers and private equity funds, mght be making plans to bid for a selection of older drugs from GlaxoSmithKline, according to Reuters, which cited sources familiar with the dealings.

July 21, 2014

Commentary published online Monday addresses the controversy surrounding the high costs of new Hepatitis C virus treatments and implications for the growing specialty pharmacy market. 

 

July 21, 2014

The Food and Drug Administration’s Center for Drug Evaluation and Research is providing an update to key leadership positions within the Office of Generic Drugs, the agency announced.